-
Luisa Gutierrez replied to the topic Discussion Topic: Vagueness of GMP's in the forum Quality Systems Management 8 years ago
With the way the GMP requirements are set up, it seems that it is trying to make any start-up companies fail. But as mentioned above, the GMP have general requirements to allow any style of company whether it is in the health industry or even food industry to mold and create an efficient process. Also, the GMP requirements was created based on issues that occurred in the past products being improperly labeled or even process inappropriately which caused the public to get sick or even dying from the product. With the GMP rules in place, it allowed to place controls over the manufacture process, packing and the types of drugs/devices based on their classification of low risk to high risk for patients.